SONIDEGIB

Other

Brand names: Odomzo

Oral

Mechanism of Action

12.1 Mechanism of Action Sonidegib is an inhibitor of the Hh pathway. Sonidegib binds to and inhibits Smoothened, a transmembrane protein involved in Hh signal transduction.

Indications

1 INDICATIONS AND USAGE ODOMZO (sonidegib) is indicated for the treatment of adult patients with locally advanced basal cell carcinoma (BCC) that has recurred following surgery or radiation therapy

or those who are not candidates for surgery or radiation therapy. ( 1 )

Contraindications

• 4 CONTRAINDICATIONS None. None. ( 4 )

FDA Warnings

5 WARNINGS AND PRECAUTIONS Embryo-Fetal Toxicity: Advise patients not to donate blood or blood products during treatment with ODOMZO and for at least 20 months after the last dose
1 Embryo-Fetal Toxicity ODOMZO can cause embryo-fetal death or severe birth defects when administered to a pregnant woman
Advise pregnant women of the potential risk to a fetus
Advise patients starting therapy with ODOMZO of the risk of muscle-related adverse reactions

Known Side Effects

7 documented side effects by frequency

Hair Loss

1-10%

Fatigue

1-10%

Nausea

1-10%

Weakness

1-10%

Weight Loss

0.1-1%

Decreased Appetite

0.1-1%

Drug Not Working

0.1-1%

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Formulations

Dosage Forms

Tablet

Route

Oral